Medicare Cuts Coverage in Image-Guided Superficial Radiotherapy, Lawsuit Filed

SkinCure Oncology has filed a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) in the US District Court for the Northern District of Illinois to challenge a policy change that eliminated Medicare reimbursement for Image-Guided Radiotherapy (IGRT) used during the treatment of non-melanoma skin cancer.¹

The plaintiff sought to overturn a 2023 CMS decision that resulted in the denial of coverage for the imaging component of GentleCure, an Image-Guided Superficial Radiotherapy (IG-SRT) procedure. SkinCure Oncology alleged that the federal agencies bypassed required administrative procedures and clinical evidence when they reclassified the imaging technical component as "always bundled," effectively removing the ability for providers to receive separate payment for the essential ultrasound guidance used to visualize tumors during treatment.

Main Data That Support the Findings

IG-RT is the only treatment option that uses ultrasound imaging to direct low-level x-rays to specific areas of the skin, that would kill the cancer cells in patients with basal and squamous cell carcinoma. Of note, the freedom from recurrence rate within the last 6 years when IG-SRT was used was more than 99%.² Furthermore, the use of IG-SRT was an equivalent to Mohs surgery and has shown statistically significant superiority in non-IG-SRT.

For clinicians who use IG-SRT for patients with non-melanoma skin cancer, further training through accredited residency and fellowship programs that are sponsored by select associations would be needed. The press release noted that the suit “suddenly and unjustifiably reverses longstanding Medicare coverage”.

Additionally, the training requirement conflicts with each state’s scope-of-practice laws, as each state delegates what physicians can or cannot do in their practices, noted Kerwin Brandt, chief executive officer of SkinCure Oncology.

"More than 140,000 patients have been successfully treated by dermatologists with this less invasive treatment option, with a 99.8% patient satisfaction rate – clear proof that dermatologists are experts in the modality and certainly not in need of additional training or certification," noted Brandt.

Use of IG-SRT in Clinical Trials

In a study published in Advances in Radiation Oncology, the 2-year freedom from recurrence for individuals with non-melanoma skin cancer was assessed.³ Of the 2880 lesions and 1602 patients who were treated primarily with IG-SRT, 22 had a recurrence of their non-melanoma skin cancer and 70 died of causes unrelated to their non-melanoma skin cancer. The 2-year recurrence rate was 0.7%. For those with basal cell carcinoma, the 1-year recurrence rate was 1.1% basal cell carcinoma, 0.8% for squamous cell carcinoma, and 0% for squamous cell carcinoma in situ.

Regulatory Action

On February 27, 2026, the American Society for Radiation Oncology (ASTRO) sent a letter to 5 Medicare Administrative Contractors regarding raising local concerns for superficial radiation therapy for the treatment of non-melanoma skin cancers.⁴ For ASTRO, the primary concern would be restricting the access of SRT administration for non-melanoma skin cancers. In turn, this would limit the access to care for Medicare beneficiaries.

While ASTRO highlights there are no data to support this limitation, several of the Medicare Administrative Contractors have acknowledged the concern, and are presenting them to a working group.

In Conclusion

"This abrupt reversal of precedent is arbitrary and capricious, lacking a reasoned explanation, and will undermine patient access to care," Brandt concluded. "The new training requirement is of particular concern, because no such program currently exists for dermatologists. Because these specialists, who provide the vast majority of IG-SRT treatment, cannot comply with this new requirement, it would effectively preclude them from providing the treatment, even though they have been safely and successfully providing it for many years," he continued. "We’re pleased and encouraged to see that other health care associations and providers across the country share our concerns about these policies, and we have a high degree of confidence that we will prevail."

References

1. SkinCure Oncology seeks federal court injunction to cease unlawful effort to strip medicare coverage for image-guided superficial radiation therapy. News release. March 6, 2026. Accessed March 10, 2026. https://tinyurl.com/3ynm2j55
2. Farberg AS, Heysek RV, Haber R, et al. Freedom from recurrence across age in non-melanoma skin cancer treated with image-guided superficial radiation therapy. Geriatrics (Basel). 2024;9(5):114. Published 2024 Sep 5. doi:10.3390/geriatrics9050114
3. McClure EM, Sedor G, Moloney M, Jin Y, Yu L, Kattan MW. Image guidance is associated with improved freedom from recurrence after superficial radiation therapy for nonmelanoma skin cancer. Adv Radiat Oncol. 2024;9(12):101463. Published 2024 Feb 9. doi:10.1016/j.adro.2024.101463
4. ASTRO sends letter to 5 MACs regarding SRT for NMSC. News release. American Society for Radiation Oncology. February 27, 2026. Accessed March 10, 2026. https://tinyurl.com/3fvpt4wh